SSE09: CRN, Nutrilite Take on FDA, GMPs and SIDI

SECAUCUS, N.J.—Representatives from the Council for Responsible Nutrition (CRN) and Nutrilite said one of the top questions FDA is asking during GMP (good manufacturing practice) inspections is how a manufacturer obtains information about raw materials and how manufacturers are qualifying their ingredient suppliers. The comments came during a panel discussion at SupplySide East about a protocol called Standardized Information on Dietary Ingredients (SIDI™).

Michelle Stout, regulatory policy director within the technical/regulatory affairs department at Amway/Nutrilite, told the audience her company was one of the first to be audited by FDA following last year’s compliance date for large companies. She said FDA asked how suppliers were qualified, how information about raw materials was obtained (including information about allergens, country of origin, etc.), and how that information was used. Nutrilite helped develop the SIDI protocol as part of an industry working group and is using it as part of its supplier qualification process. The SIDI protocol has cut the turnaround time for suppliers to provide necessary information from one to four weeks to one to three days, according to Stout.

Andrew Shao, Ph.D., CRN’s vice president of scientific and regulatory affairs, told SupplySide East attendees FDA asked all four of the industry associations what members are doing to qualify suppliers. Shao said FDA has not defined how it wants supplier qualification handled, but he suggested the SIDI program is a good first step. He also provided attendees with data from a new survey of manufacturers and suppliers regarding their use of and experience with the SIDI protocol. According to the survey, the two main benefits cited by SIDI users were improved FDA and third party inspections, and reductions in resources and expenses attributed to supplier qualification.

The SIDI protocol is an outline of the type and scope of information that an ingredient supplier typically needs to provide to a manufacturer. It was developed by a working group that included American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), CRN and Natural Products Association (NPA), as well as more than a dozen leading manufacturers and suppliers. Details about the protocol are available from any of the four trade associations involved in its development.